A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia

Cancer, Therapy-Related Clinical Trial

Official title:

A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376435
• Other study ID #: HBHQ-CTIT-RWS
• Status: Not yet recruiting
• Start date: April 20, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2024
• Source: Hebei Medical University Fourth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world. The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia. This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values < 100×109/L during radioimmunotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Understand the research procedure and voluntarily sign the informed consent to participate in the study
• Subjects =18 years of age receiving synchronous/sequential chemotherapeutic therapy
• Patients with platelet count =100×109/L or platelet count decrease = 50×109/L or platelet count > 100×109/L but need to be prophylaxis with hexapopethanolamine tablets
• Researchers believe that subjects need to be treated with hexapopal.

Exclusion Criteria:

• The subjects are conducting clinical intervention studies
• Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar
• Pregnant or lactating women
• Other conditions deemed unsuitable for inclusion in the study by the researcher.

Related Conditions & MeSH terms

• Cancer, Therapy-Related
• Neoplasms, Second Primary
• Thrombocytopenia

Intervention

Drug:
• Herombopag Olamine Tablets
Herombopag Olamine;combined rhTPO;combined IL-11

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients recovered to 100×109/L	The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied	14 days after starting treatment with the study drug
Secondary	The proportion of patients recovered to 75×109/L	The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied	up to 2 months
Secondary	Time for platelet recovery to 100×109/L	Study the time for platelet recovery to 100×109/L after drug initiation	up to 2 months
Secondary	Proportion of patients with treatment delay or dose reduction	Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc	up to 2 months
Secondary	TRAE	Study drug-related adverse reactions	up to 2 months